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CFSAN/Office of Food Additive Safety
June 20, 2000
Date: June 20, 2000
From: Chemistry and Environmental Review Team
Division of Product Policy (HFS-205)
Subject: Premarket Notification (FCN No. 000080) for 2, 6-Di-tert-butyl-4-sec-butylphenol for Use as an Antioxidant in Plasticized PVC
Notifier: Schenectady International, Inc.
c/o Keller and Heckman
Washington, D.C. 20001
To: Division of Petition Control (HFS-215)
Attention: Vivian Gilliam
Attached is the Finding of No Significant Impact (FONSI) for the above-cited Premarket Notification. When this notification becomes effective, the environmental assessment and FONSI should be made available to the public. Please let me know if there is any change in the identity or use of the food-contact substance that would be inconsistent with the identity and use described in the FONSI.
Layla I. Batarseh, Ph.D.
A Premarket Notification (FCN No. 000080), submitted by Schenectady International, Inc., to provide for the safe use of 2, 6-di-tert-butyl-4-sec-butylphenol (CAS Reg. No. 17540-75-9) as an antioxidant in plasticized vinyl chloride homo- and copolymers (PVC) used in contact with all types of food under Conditions of Use C through G as set forth in 21 CFR 176.170(c), Table 2.
The Chemistry and Environmental Review Team has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and therefore will not require the preparation of an environmental impact statement. This finding is based on an environmental assessment prepared by the notifier.
Prepared by: _____________________________________________ Date: June 2, 2000
Layla I. Batarseh, Ph.D., Team Leader
Chemistry and Environmental Review Team
Division of Product Policy
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration
